Table 3. Biomarkers for efficacy in all patients evaluated for the extension arm at week 12.

Biomarker	Week 0 (n=20)				Week 12 (n=20)				Week 20 (n=15)				Week 26 (n=14)				Week 52 (n=6)
	Median	Q1	Q3		Median	Q1	Q3		Median	Q1	Q3		Median	Q1	Q3		Median	Q1	Q3
PSA	40	15	67		64*	40	102		78	35	127		71	35	218		72	41	252
Hgb	8.3	7.9	8.7		7.8*	7.5	8.2		7.8	7.4	8.2		8.1	7.4	8.3		7.6	6.4	7.9
LDH	196	180	217		209	188	230		194	181	259		214	172	243		194	184	208
ALP	81	68	99		85*	65	122		84	74	142		89	70	214		93	85	100
Albumin	42	39	43		41	40	45		41	39	43		43	39	44		42	40	45
bALP	29	21	41		29*	22	67		32	22	57		46	21	116		34	28	38
PINP	46.5	17.0	95.0		51.4*	21.4	174		55.1	29.6	136		73.6	28.3	146		43.5	37.6	55.8
uNTx	57.0	20.2	78.8		52.5*	35.3	119		45.8	21.9	97.3		49.9	31.3	83.3		67.0	48.0	140
YKL-40	72	38	107		82	53	143		132	63	155		78	58	140		192	145	242
8-oxo-G	28.8	25.5	39.9		31.4*	28.0	41.3		–	–	–		–	–	–		–	–	–
8-oxo-dG	17.9	15.7	24.4		17.0	15.7	23.3		–	–	–		–	–	–		–	–	–

*, P<0.05, week 12 compared with baseline. PSA, prostate-specific antigen (µg/L, ref. <4); Hgb, hemoglobin (mmol/L, ref. 8.3–10.5); LDH, lactate dehydrogenase (U/L, ref. 115–255); ALP, alkaline phosphatase (U/L, ref. 35–105); Albumin (g/L, ref. 34–45); PINP, pro-collagen type 1 N-terminal (µg/L); bALP, bone-specific alkaline phosphatase (U/L, ref. 12–44); uNTx, urinary type I collagen cross-linked N telopeptides (nmol/µmol urine creatinine, ref. 21–83); YKL-40 (ng/mL, ref. 14–155); 8-oxo-dG, 8-oxo-7,8-dihydro-2’-deoxyguanosine (nmol); 8-oxo-G, 8-oxo-guanosine (nmol).